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Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).

2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (Sativex), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (placebo)

Drug: Sativex®

THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients.

Duration: 2 weeks

Drug: Placebo

Placebo

Same frequency and dosage form as Sativex.

Duration: 2 weeks

Experimental: first placebo, second sativex

2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (placebo), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (Sativex)

Drug: Sativex®

THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Aged 18 years or above

Willing and able to comply with the protocol for the duration of the study

Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least 12 months

Relapse free from at least 3 months before screening visit

Lower limb spasticity

EDSS from > 3.0 and < 6.5

Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment

Immunomodulatory or immunosuppressant therapies not modified during the study and 6 months before starting the study